Spots Global Cancer Trial Database for PRevention Using EPA Against coloREctal Cancer

Study Description

Brief Summary: This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. - The name of the study drug involved in this study is: -- AMR101 (VASCEPA).

Detailed Description: This prospective, single-arm, research study evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. * AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body. * The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for any disease. * AMR101 is commercially available in the US as VASCEPA (icosapent ethyl) * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, including: * Lifestyle questionnaire, * Nutritional survey * Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample) * Blood samples, * AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial